Most of us know that a BA/BE study of a generic can be done without an IND (the exception, called a Bio-IND, is when the drug being studied is cytotoxic or a radioactive labeled drug). In 505(b)(2) drug development we often are studying the BA/BE of a test drug versus an RLD as part of [...]
Archive for October, 2010
505(b)(2)s with Minimal Sponsor Studies
Published October 6th, 2010 in 505(b)(2) Process. 0 CommentsThe power of the 505(b)(2) process is realized when the sponsor has to conduct few, if any, studies to get their drug product approved. For many drugs there is wealth of data available in the public domain. The challenge is locating the data and then preparing it for the FDA in such a way that [...]
Why have a Quality Overall Summary for the Quality Module?
Published October 5th, 2010 in CMC Issues and How to:. 0 CommentsThe Quality Module (Module 3 or Chemistry, Manufacturing and, Controls section (CMC)) in the eCTD format serves as the backbone of any regulatory submission, an IND or NDA. We have discussed this in a previous blog posting. There is debate about the usefulness of the Quality Overall Summary (QOS or Module 2.3 of eCTD) with [...]
Company Officials Personally Liable
Published October 18th, 2010 in News Commentary. 0 CommentsAs part of what appears to be an increasingly aggressive enforcement stance, there have recently been a number of statements coming from FDA in several settings suggesting that an increase in the number of prosecutions of senior corporate individuals is imminent. In the past, FDA and the Department of Justice have initiated a fair number [...]